Tsis ntev los no, cov neeg tau txais lus nug txog cov teeb meem cuam tshuam nrog "teeb tsa cov khoom noj khoom haus khoom noj khoom haus Ntawm no, Kuv xav qhia cov kev pom hauv cov ncauj lus uas peb-raws li cov lag luam feem ntau saib xyuas. (DAWB sab hauv cov ntaub ntawv rau koj siv.)
I. Pib Lub Tsev Haujlwm Hauv Zej Zog Hauv Tebchaws Meskas: Ib Phau Ntawv Qhia Rau Cov Khoom Siv
1.
FDA Khoom Noj Khoom Haus Tsev Kawm Ntawv: Txhua lub tsev nyob txawv teb chaws lossis txawv teb chaws koom nrog hauv cov zaub mov, kev ua haujlwm, ntim, yuav tsum sau npe nrog FDA. Nov yog daim pib "nkag" rau cov khoom noj khoom haus kom nkag mus rau Asmeskas kev ua lag luam.
Kev txhais lus Rationale: (Nkag Daim pib) yog colloquial tseem ua piv txwv qhia, raws li lus Askiv idiomatic cov lus qhia kom hais txog nws lub luag haujlwm tseem ceeb. FDA cov ntawv sau npe yuav tsum tau ua raws li kev cai lij choj rau kev nyab xeeb, yog li kev pom tseeb ntawm kev ua lag luam ntawm cov neeg lag luam kom pom tseeb.
2.
CBP Bonds tsis yog - kev sib ceg: Yog tias koj cov khoom lag luam txawv tshaj $ 2,500 hauv tus nqi lossis yuav tsum tau nkag mus (kev nkag teb chaws), koj yuav tsum yuav cov kev lis kev cai sib cog lus (CBP Bond). Qhov no yog qhov "ua -} {- break txoj kab" rau kev ua kom du cathance.
Kev txhais lus Rationale: (ua rau {-}} - break kab) convey break kab) convert cov stakes cowance. Hauv Asmeskas kev cai lij choj kev cai, ib qho kev ua haujlwm raws li kev ua haujlwm nyiaj txiag, txiav txim siab rau kev zam kev thauj khoom qeeb lossis qaug dab peg.
3.
FSVP cov ntaub ntawv tsis zoo: Raws li ib tus neeg rho tawm, koj yuav tsum ua raws li cov chaw pabcuam neeg txawv teb chaws (FSVP). Qhov no yuav tsum tau xyuas tias koj cov chaw muag khoom txawv teb chaws ntsib Asmeskas cov qauv kev nyab xeeb thiab tau txais ib tus naj npawb kev nyab xeeb (DunSt}
Kev txhais lus Rationale: Tuav cov ntawv sau ua ke xws li FSVP thiab D - u} u} s (nrog tag nrho cov npe tau muab) muab cov nqi tshaj lij thiab nyeem tau. Lub FSVP yog qhov tseem ceeb FDA kev cai nyob rau hauv cov kev nyab xeeb kev nyab xeeb modyization kev tswj hwm rau peb cov nyeem paub nrog Asmeskas cov qauv.
4.
Sau npe thiab ua raws cai yog qhov tseem ceeb: Pre6 {-}}}}}}} Kuv cov ntaub ntawv sib xyaw, cov lus qhia khoom noj, cov khoom siv khoom noj muaj cov ntawv sau tshwj xeeb.
Kev txhais lus Rationale: ((lub ntsiab lus) hais txog qhov tsis - Hais tau qhov tseem ceeb ntawm daim ntawv sau npe ua raws cai. Teb Chaws Asmeskas FDA (21 CFR Ntu 101) Cov ntawv lo lus sau ntawv Askiv rau cov neeg siv kev nyab xeeb thiab qhia txog qhov no nrog kev cia siab hauv zos.
Ii. 4 Cov kauj ruam tom ntej yog kev tso npe rau US tuam txhab?
Tom qab sau npe rau Asmeskas cov tuam txhab, cov txuj ci tseem ceeb thiab cov kev tseev kom muaj dab tsi koj xav tau rau zaub mov ntshuam thiab muag khoom? (Saib daim duab hauv qab no.)
1.
FDA Sau npe thiab ua raws cai yuav tsum muaj
2.
Kev lis kev cai thiab import kev ua raws (CBP)
{{0 {}}} ob lub ntsiab lus no tau them rau cov ntawv dhau los; Xav tias dawb los tshuaj xyuas yav dhau los nkag.
3.
Xeev thiab zos -} qib tso cai
Cia peb tsom rau qhov no -}}}}}}} Tshaj hauv tsoomfwv yuav tsum muaj, koj yuav tsum tau tso cai tshwj xeeb rau koj lub lag luam lub xeev thiab lub nroog. Cov kev sib txawv no los ntawm xeev, nroog, thiab nroog, yog li ib txwm txheeb xyuas nrog cov tub ceev xwm hauv zej zog.
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Daim ntawv tso cai ua lag luam hauv xeev: Feem ntau cov xeev xav tau kev lag luam los tuav daim ntawv tso cai ua haujlwm.
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Resale Tso Cai / Muag Khoom Daim Ntawv Tso Cai: Yuav tsum tau yog tias koj npaj yuav cov khoom Resell (piv txwv li, hauv lub tsev loj). Nws ua rau khaws cov se ntawm kev muag khoom thiab zam koj los ntawm kev them se muag ntawm kev yuav khoom lag luam.
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Daim Ntawv Tso Cai Muag Khoom Muag: Tshaj tawm los ntawm lub xeev lossis chav saib xyuas kev noj qab haus huv hauv zos, qhov kev tso cai muag khoom noj rau cov pej xeem.
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Lwm Cov Ntawv Tso Cai: Yuav muaj cov tuam tsev noj qab haus huv
4.
Kev ua raws cai tshwj xeeb rau kev khaws cia khoom noj thiab muag khoom
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Labeling zaub mov: Txhua {-}}}}}}}}}}} puas muaj cov ntawv Askiv ua raws cov cai FDA. Cov ntsiab lus uas yuav tsum muaj xws li: cov npe khoom lag luam, cov npe thiab cov khoom siv tsis zoo, yog siv tau), thiab hnub tas sijhawm / hnub.
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Cov Qauv Kev Nyab Xeeb Khoom Noj: Xyuas kom meej tias cov zaub mov txawv teb thiab muag tau raws li peb kev nyab xeeb ntawm kev nyab xeeb, xws li:
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Kev Tsim Kho Zoo (GMP): Ua kom cov khoom noj yog tsim tawm, ua tiav, ntim, thiab khaws cia hauv cov kab mob huv.
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HACCP phiaj xwm: Yuav tsum muaj siab rau high - Cov zaub mov pheej hmoo thiab nqaij, koom nrog cov ntsiab lus kev phom sij thiab tswj kev phom sij.
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Chaw thiab chaw cia khoom: Koj lub khw muag khoom lag luam thiab cov txee yuav tsum dhau lub tuam tsev pab kev noj qab haus huv hauv cheeb tsam, kev tswj hwm ntsuas kub, thiab kev tiv thaiv kab tsuag, thiab kev tiv thaiv kab tsuag, thiab kev tiv thaiv kab tsuag, thiab kev tshuaj tua dej.
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Kev Kawm Ua Haujlwm: Qee lub xeev cov neeg ua haujlwm muab khoom noj kom tiav los ua kom muaj kev cob qhia txog kev nyab xeeb zaub mov thiab muab cov ntawv pov thawj (piv txwv li daim npav tuav khoom noj).
Hauv cov ntsiab lus, qhib ib lub tsev lag luam Suav hauv Asmeskas thiab kev xa khoom noj ntawm Tuam Tshoj koom nrog cov kev xav tau nyuaj. Txawm li cas los xij, los ntawm kev daws cov tsoomfwv (FDA, CBP), xeev, thiab cheeb tsam thiab hauv cheeb tsam}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}}. Cov tub ntxhais nyob hauv FDA kev ua raws cai (rau npe, FSVP, Labeling) thiab kev lis kev cai txiav txim siab (BRIFFS). Npaj kom nqis peev tau los nqis peev lub sijhawm thiab muaj peev xwm txog ntau txhiab nyiaj (feem ntau rau cov nqi ua npe, thiab tus nqi sau npe) kom tiav cov txiaj ntsig kev npaj tshiab no.
